Delta-9-Tetrahydrocannabinol (also known as THC, dronabinol and Δ9-THC) is a naturally occurring compound and is the primary active ingredient in the controlled substance marijuana. Marijuana refers to the dried flowers and leaves of Cannabis Sativa, the hemp plant. These parts of the plant contain several compounds called cannabinoids (including dronabinol), that may help patients with certain disease conditions.
Currently, dronabinol is commercially available in the U.S. as a sesame oil solution in a soft gelatin capsule under the tradename Marinol® from Unimed Pharmaceuticals, Inc., which is orally administered. Upon oral administration, the gelatin dissolves, releasing the drug. The dronabinol dissolved in sesame oil is then absorbed during its passage through the gastrointestinal tract. The Marinol® soft gelatin capsule form of dronabinol is highly unstable at room temperature, and it is required that the product be stored at refrigerated (2-8° C.) or cool (8-15° C.) conditions (Marinol® package label, Physicians Desk Reference®, ed. 2003). Additionally, Marinol® should be packaged in a well-closed container.
The need to store Schedule III Dronabinol product in a refrigerator is a major disadvantage for a pharmaceutical product. Accordingly, there is a need for developing a room temperature stable Dronabinol product that addresses problems associated with the storage of a Drug Enforcement Agency (DEA) Scheduled product (i.e., a controlled substance) at refrigerated conditions and patient convenience.